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Body Parameters as an Independent Predictor of Acute Pancreatitis

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ClinicalTrials.gov Identifier: NCT03482921
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Ningbo No. 1 Hospital

Tracking Information
First Submitted Date March 23, 2018
First Posted Date March 29, 2018
Last Update Posted Date March 29, 2018
Actual Study Start Date December 1, 2017
Actual Primary Completion Date February 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 23, 2018)
  • Comparisons of variables according to AP severity [ Time Frame: the physical examination data in the year of 2017 ]
    Comparisons of variables according to AP severity by one-way analysis of variance (ANOVA) and Likelihood Ratio
  • Relationships between VAT and severity outcomes Relationships between VAT and severity outcomes Relationships between VAT and severity outcomes Relationships between body parameters and severity outcomes [ Time Frame: the physical examination data in the year of 2017 ]
    Relationships between VAT and severity outcomes by Likelihood Ratio
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Body Parameters as an Independent Predictor of Acute Pancreatitis
Official Title Body Parameters as an Independent Predictor of Acute Pancreatitis: A Propensity Score-matched Case-control Study
Brief Summary This study is to assess the predictive significance of visceral adipose tissue (VAT) and visceral adipose tissue /skeletal muscle tissue ratio (VAT/SMT ratio) for the prognosis in acute pancreatitis (AP) patients.
Detailed Description

Acute pancreatitis (AP) is a sudden inflammation of the pancreas. However, one-fifth of patients may develop severe complications with a mortality between 10%-20% It remains a difficulty to find an effective method for prediction of severity of AP at early stage.

It is well-established that obesity (defined as body mass index[BMI]>30kg/m2 by the World Health Organization) is a risk factor for AP and increases the incidence of systemic complication, motality. There are a lot of parameters related to saropenic obesity, including areas of visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), skeletal muscle tissue (SMT), and VAT/SMT ratio. it is unclear which parameter is the best predictor of severe AP. Thus, this study is aimed to investigate the association between these parameters and AP severity and find the best predictor of AP.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration 7 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Diagnosis criteria for AP was defined as the presence of at least 2 of the 3 following factors: (1) abdominal pain characteristic of AP; (2) serum amylase and/or lipase levels≥3 times the upper limit of the normal level, and (3) characteristic findings of AP on a CT scanning.
Condition Acute Pancreatitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Xie J, Xu L, Pan Y, Li P, Liu Y, Pan Y, Xu L. Impact of visceral adiposity on severity of acute pancreatitis: a propensity score-matched analysis. BMC Gastroenterol. 2019 Jun 13;19(1):87. doi: 10.1186/s12876-019-1015-z.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 23, 2018)
1662
Original Actual Enrollment Same as current
Actual Study Completion Date March 22, 2018
Actual Primary Completion Date February 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. diagnosed with AP
  2. age >18 years

Exclusion Criteria:

  1. age<18years
  2. missing data in the electronic medical record
  3. history of AP
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03482921
Other Study ID Numbers Ningbo4
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ningbo No. 1 Hospital
Study Sponsor Ningbo No. 1 Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Lei Xu, Dr Department of gastroenterology, Ningbo No.1 Hospital, Ningbo, China
PRS Account Ningbo No. 1 Hospital
Verification Date March 2018